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The US Food and Drug Administration (FDA) has warned Sprout Pharmaceuticals for the second time concerning its promotion of its hypoactive sexual desire disorder (HSDD) drug Addyi. The agency also sent a warning letter to a company for conducting a clinical investigation without submitting an investigational new drug application (IND).

Sprout Pharmaceuticals' promotion of Addyi both mischaracterizes the drug's indication and downplays potential serious adverse events associated with its use, according to a warning letter from the US Food and Drug Administration (FDA).

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Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely.

Following the completion of postmarketing studies for Sprout Pharmaceuticals' Addyi (flibanserin), which is used to treat decreased sexual desire in women, the US Food and Drug Administration (FDA) has changed the labeling for the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely.

In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week.

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the highest number of NMEs approved in any year except 1996.

OPDP found fault with an interview with Khloé Kardashian, who was paid by Biohaven as a spokesperson; the videotaped interview aired on 15 July on the ABC TV show The View and was later posted to the show's YouTube page, according to the letter.

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.